Affimed N.V. (NASDAQ: AFMD) shares dropped sharply early on Friday after the company released new results from its early stage trial with Keytruda. Affimed presented new interim data from the Phase 1b dose escalation study evaluating AFM13, its lead NK cell engager candidate, at the European Hematology Association (EHA) 23rd Congress in Stockholm, Sweden
Ultimately, the assessment of 18 patients treated at the highest AFM13 dose showed best overall response rate (ORR) of 89% and complete metabolic response rate (CmR) of 28%. The ORR and CmR for these 18 patients compare favorably with those of anti-PD-1 monotherapy in similar patient populations.
Responders included three patients who were either primary refractory to or had relapsed during front-line therapy and were refractory to all subsequent lines of therapy.
The combination of AFM13 and pembrolizumab was well tolerated, with most adverse events mild to moderate in nature and manageable with standard of care measures.
Dr. Stephen Ansell, principal investigator of the study, commented:
The high response rates in this study, in terms of both partial and complete responses, continue to compare favorably to the historical data of anti-PD-1 monotherapy, and would be expected to translate into meaningful progression free and overall survival over time. Importantly, these data have shown that AFM13 can be safely administered in combination with Keytruda® and has the potential to improve patient outcomes.
Shares of Affimed closed Thursday at $2.45, with a consensus analyst price target of $7.43 and a 52-week range of $1.15 to $2.85. The shares were down 15% to $2.07 Friday morning.